MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that guidewire break occurred.The target lesion was located in a mid-left anterior descending (lad) artery.During left heart catheterization, the fractional flow reserve (ffr) procedure was chosen to see if the lesion actually needed to be treated.The reported comet ffr pressure guidewire, 185cm was selected.It was noted that the entire procedure was highly successful.Then an intervention was performed.It was noted that the intervention was highly successful as well.After the intervention, the ffr was attempted to be performed using the same comet guidewire.While inserting the comet guidewire into the touhy, the physician encountered resistance and the guidewire got kinked, snapped and broke into two pieces.None of the wire pieces were in the patient.The procedure was completed without performing ffr.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a ffr comet wire in two pieces.Visual inspection of the device revealed no other damage or irregularities.The guidewire was completely separated 32.5cm from the distal tip.The proximal fracture to the seam weld was 5cm.Magnified inspection of the fracture surface appears to be consistent with separation due to ductile bending overload.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors.(b)(4).

Event Description

It was reported that guidewire break occurred.The target lesion was located in a mid-left anterior descending (lad) artery.During left heart catheterization, the fractional flow reserve (ffr) procedure was chosen to see if the lesion actually needed to be treated.The reported comet ffr pressure guidewire, 185cm was selected.It was noted that the entire procedure was highly successful.Then an intervention was performed.It was noted that the intervention was highly successful as well.After the intervention, the ffr was attempted to be performed using the same comet guidewire.While inserting the comet guidewire into the tuohy, the physician encountered resistance and the guidewire got kinked, snapped and broke into two pieces.None of the wire pieces were in the patient.The procedure was completed without performing ffr.No patient complications were reported.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5347147
• MDR Text Key: 35207681
• Report Number: 2134265-2015-09171
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: H7495551110
• Device Lot Number: 18615065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR